The British journal of surgery
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Randomized Controlled Trial Clinical Trial
Triple therapy and incidence of de novo cancer in renal transplant recipients.
Some 27 (5.5 per cent) of 492 renal transplant recipients developed de novo cancer between January 1975 and December 1991. Patients administered triple therapy of prednisolone, cyclosporin A and azathioprine had a significantly higher incidence of cancer (seven of 40 patients; 17.5 per cent) than those given prednisolone with cyclosporin (14 of 319; 4.4 per cent) and azathioprine with prednisolone (six of 133; 4.5 per cent) (P = 0.005). ⋯ The incidence of cancer in patients receiving low-dose cyclosporin, azathioprine and prednisolone was three of 45, in those given high-dose cyclosporin and prednisolone none of 23 and in those administered high-dose cyclosporin, nifedipine and prednisolone one of 29. The addition of azathioprine to ongoing maintenance cyclosporin and prednisolone therapy is useful in a subgroup of patients with graft dysfunction, but there are possibly higher risks in the development of de novo carcinoma.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Prospective study of 713 below-knee amputations for ischaemia and the effect of a prostacyclin analogue on healing. Hawaii Study Group.
In 51 hospitals in six European countries 713 patients requiring below-knee amputation for ischaemic disease were studied prospectively. The patients were allocated randomly to receive standard postoperative treatment or standard treatment plus intravenous infusion of the prostacyclin analogue iloprost for 6 h per day over 14-21 days. Healing of the amputation stump and the need for reamputation at a higher level were similar in the two groups. ⋯ Preoperative characteristics were analysed as possible risk factors or markers for primary healing, reamputation and death. Previous arterial reopening procedures (surgical or radiological) almost doubled the chances of primary stump healing (P < 0.05). The surgeon's assessment of the likelihood of healing was wrong in 21 per cent of cases in which the operating surgeon thought that healing would probably occur and in 52 per cent of those in which it was thought healing was improbable.
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Randomized Controlled Trial Comparative Study Clinical Trial
Randomized controlled trial comparing laparoscopic and open appendicectomy.
A study was carried out of 137 patients with a diagnosis of acute appendicitis who were randomized to either laparoscopic or open appendicectomy. Patients found to have perforated or normal appendices at histological examination were excluded. Fifty-two patients undergoing laparoscopic appendicectomy and those receiving 57 open procedures were analysed. ⋯ There were five (9 per cent) wound infections after open appendicectomy compared with none after the laparoscopic operation (P < 0.01). Patients who underwent laparoscopy returned to full home (17 versus 30 days, P < 0.01) and social (19 versus 32 days, P < 0.05) activities earlier than those who underwent open operation. Laparoscopic appendicectomy may allow reduction in the number of wound infections and earlier return to normal activities.
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Randomized Controlled Trial Clinical Trial
Randomized controlled trial of the effect of sulindac on duodenal and rectal polyposis and cell proliferation in patients with familial adenomatous polyposis.
Twenty-four patients with familial adenomatous polyposis who had previously undergone prophylactic colectomy and had advanced duodenal polyposis were entered into a randomized trial to assess the effect of the non-steroidal anti-inflammatory drug sulindac on duodenal and rectal polyps. Polyp size and number were assessed by videotaped duodenoscopy (and rectoscopy in 14 patients) at entry and after 6 months of treatment; the tapes were compared by two assessors who were unaware of the randomization and the shuffled chronological order of the recordings. Mucosal cell proliferation was measured by in vitro incorporation of 5-bromo-2'-deoxyuridine. ⋯ In the rectum, cell proliferation showed a marked reduction (median LI 8.5 versus 7.4 per cent, P = 0.018), and significant (P = 0.01) polyp regression was seen. Rectal polyposis was less severe than that in the duodenum and responded more dramatically. Sulindac is a possible treatment for patients in whom rectal polyps have failed to show significant regression after ileorectal anastomosis and who are unsuitable for pouch surgery; it may be useful in early duodenal polyposis or as an adjunct after duodenal clearance.
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Randomized Controlled Trial Clinical Trial
Suture length to wound length ratio and healing of midline laparotomy incisions.
The effect of suture length to wound length ratio on the healing of midline laparotomy wounds closed with a continuous suture was evaluated in a prospective clinical trial. All patients undergoing abdominal procedures through a midline incision were included except those with an incisional hernia after previous midline operation. The total incidence of wound infection was 36 of 454 patients (7.9 per cent) and wound dehiscence requiring reoperation occurred in three patients (0.7 per cent). ⋯ Multivariate analysis identified the suture length to wound length ratio, age and major wound infection as independent risk factors for the development of hernia, which occurred in 9.0 per cent of patients when the suture length to wound length ratio was > or = 4 and in 23.7 per cent (P = 0.001) when it was < 4. The suture length to wound length ratio is an important parameter for healing of midline incisions closed with a continuous suture technique. The incidence of incisional hernia is lower when such wounds are sutured with a ratio > or = 4.